Dataset Information

Statins Have No Additional Benefit for Pulmonary Hypertension: A Meta-Analysis of Randomized Controlled Trials.

ABSTRACT:

Objectives

We performed a meta-analysis to explore the effects of adding statins to standard treatment on adult patients of pulmonary hypertension (PH).

Methods

A systematic search up to December, 2015 of Medline, EMBASE, Cochrane Database of Systematic reviews and Cochrane Central Register of Controlled Trials was performed to identify randomized controlled trials with PH patients treated with statins.

Results

Five studies involving 425 patients were included into this meta-analysis. The results of our analysis showed that the statins can't significantly increase 6-minute walking distance (6MWD, mean difference [MD] = -0.33 [CI: -18.25 to 17.59]), decrease the BORG dyspnea score (MD = -0.72 [CI: -2.28 to 0.85]), the clinical worsening risk (11% in statins vs. 10.1% in controls, Risk ratio = 1.06 [CI: 0.61, 1.83]), or the systolic pulmonary arterial pressure (SPAP) (MD = -0.72 [CI: -2.28 to 0.85]). Subgroup analysis for PH due to COPD or non-COPD also showed no significance.

Conclusions

Statins have no additional beneficial effect on standard therapy for PH, but the results from subgroup of PH due to COPD seem intriguing and further study with larger sample size and longer follow-up is suggested.

SUBMITTER: Wang L

PROVIDER: S-EPMC5167271 | biostudies-literature | 2016

REPOSITORIES: biostudies-literature

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Publications

Statins Have No Additional Benefit for Pulmonary Hypertension: A Meta-Analysis of Randomized Controlled Trials.

Wang Lin L Qu Moying M Chen Yao Y Zhou Yaxiong Y Wan Zhi Z

PloS one 20161219 12

<h4>Objectives</h4>We performed a meta-analysis to explore the effects of adding statins to standard treatment on adult patients of pulmonary hypertension (PH).<h4>Methods</h4>A systematic search up to December, 2015 of Medline, EMBASE, Cochrane Database of Systematic reviews and Cochrane Central Register of Controlled Trials was performed to identify randomized controlled trials with PH patients treated with statins.<h4>Results</h4>Five studies involving 425 patients were included into this met ...[more]

PMID: 27992469

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Project description:In 2012, the United States Food and Drug Administration (FDA) issued a warning regarding potential adverse effects of HMG-CoA reductase inhibitors (statins) on cognition, based on the Adverse Events Reporting System and a review of the medical literature. We aimed to synthesize randomized clinical trial (RCTs) evidence on the association between statin therapy and cognitive outcomes.We searched MEDLINE, EMBASE, and Cochrane CENTRAL through December 2012, and reviewed published systematic reviews of statin treatment. We sought RCTs that compared statin treatment versus placebo or standard care, and reported at least one cognitive outcome (frequency of adverse cognitive events or measurements using standard neuropsychological cognitive test scores). Studies reporting sufficient information to calculate effect sizes were included in meta-analyses. Standardized and unstandardized mean differences were calculated for continuous outcomes for global cognition and for pre-specified cognitive domains. The main outcome was change in cognition measured by neuropsychological tests; an outcome of secondary interest was the frequency of adverse cognitive events observed during follow-up.We identified 25 RCTs (all placebo-controlled) reporting cognitive outcomes in 46,836 subjects, of which 23 RCTs reported cognitive test results in 29,012 participants. Adverse cognitive outcomes attributable to statins were rarely reported in trials involving cognitively normal or impaired subjects. Furthermore, meta-analysis of cognitive test data (14 studies; 27,643 participants) failed to show significant adverse effects of statins on all tests of cognition in either cognitively normal subjects (standardized mean difference 0.01, 95% confidence interval, CI, -0.01 to 0.03, p?=?0.42) or Alzheimer's disease subjects (standardized mean difference -0.05, 95% CI -0.19 to 0.10, p?=?0.38).Statin therapy was not associated with cognitive impairment in RCTs. These results raise questions regarding the continued merit of the FDA warning about potential adverse effects of statins on cognition.

Project description:To examine whether the benefit of statins varied according to cardiovascular (CV) and non-CV mortality of the treated population.Meta-analysis and meta-regression of 16 randomized placebo-controlled trials.Community and hospital.Statin- (n = 59,671) and placebo-treated (n = 59,707) individuals with and without CV disease (mean age 55 to 75).Meta-regression was used to model relative risks (RRs) of major CV events (myocardial infarction and stroke) and total mortality for statins versus placebo as a function of CV and non-CV mortality risks of the study population.Every 1% increase in 5-year non-CV mortality risk of the study population was associated with a 3.7% (95% confidence interval (CI) = 1.2 to 6.3%) greater RR of major CV events and a 4.4% (95% CI = 2.1 to 6.9%) greater RR of total mortality. (Higher RRs indicate smaller benefits.) CV mortality was not associated with statin effects (P > .05). In stratified analysis according to CV (?5.3% vs <5.3%) and non-CV mortality (?3.8% vs <3.8%) of the study population, statins had little mortality benefit in populations with high non-CV mortality, regardless of CV mortality (random-effects pooled RR = 0.81, 95% CI = 0.72 to 0.91, for low CV and low non-CV mortality; random-effects pooled RR = 0.90, 95% CI = 0.76 to 1.06 for low CV and high non-CV mortality; random-effects pooled RR = 0.79, 95% CI = 0.72 to 0.87 for high CV and low non-CV mortality; random-effects pooled RR = 0.94, 95% CI = 0.87 to 1.02 for high CV and high non-CV mortality). The CV event reduction was also attenuated in populations with high non-CV mortality (random-effects pooled RR = 0.67, 95% CI = 0.60 to 0.75, for low CV and low non-CV mortality; random-effects pooled RR = 0.73, 95% CI = 0.66 to 0.81 for low CV and high non-CV mortality; random-effects pooled RR = 0.77, 95% CI = 0.69 to 0.87 for high CV and low non-CV mortality; random-effects pooled RR = 0.83, 95% CI = 0.74 to 0.92 for high CV and high non-CV mortality).Benefits of statins may depend on the non-CV mortality risk of the treated population. This should be confirmed using individual-level data.

Project description:BackgroundThe burden of depressive disorder is large and new treatment approaches are required. Repurposing widely available drugs such as statins may be a time- and cost-effective solution. Statins have anti-inflammatory and anti-oxidant properties which have been shown to be relevant to the pathophysiology of depression. This study assesses the efficacy, acceptability, tolerability, and safety of statins in major depressive disorder.MethodsOur study is an update and extension of a previous meta-analysis published in 2016 by Salagre et al. We performed a systematic review (PubMed/MEDLINE, Cochrane CENTRAL, ISI Web of Science, CINAHL, and ClinicalTrials.gov until the 1st September 2020) and meta-analysis of randomized controlled trials using any statin against placebo or any other statin in the treatment of major depressive disorder. Our primary efficacy outcome measure was the mean value on any standardized scale for depressive symptoms at 8 weeks of treatment. We also calculated outcomes for efficacy, response, and remission at 2, 4, and 12 weeks, as well as acceptability (dropouts for any cause), tolerability (dropouts due to any adverse event), and safety (any adverse event) outcomes at the studies' endpoints. Furthermore, we conducted an exploratory network meta-analysis for the primary efficacy outcome to identify potential differences between statins.ResultsWe retrieved five randomized controlled trials meeting our inclusion criteria: four used a statin in addition to an antidepressant and compared it to placebo plus antidepressant, and one compared two statins alone. and one comparing one statin with another. Statins compared to placebo in addition to antidepressants were efficacious at 8 weeks (N = 255, SMD = -0.48, 95% CI = -0.74 to -0. 22) and 12 weeks (N = 134, SMD = -0.47, 95% CI = -0.89 to -0.05, moderate certainty) with no difference for acceptability, tolerability, and safety (low certainty). An exploratory network meta-analysis suggested that the most lipophilic statins, especially simvastatin, could be more efficacious than less lipophilic or hydrophilic molecules.ConclusionsThis systematic review suggests the efficacy, acceptability, tolerability, and safety of statins in addition to antidepressants in patients with major depressive disorder. Further clinical trials in different settings are required to test this result.Trial rgistrationPROSPERO registration: CRD42020170938.

Project description:Limited data about the long-term prognosis and response to therapy in pulmonary arterial hypertension patients with World Health Organization functional class I/II symptoms are available. PubMed and Embase were searched for publications of observational registries and randomized, controlled trials in pulmonary arterial hypertension patients published between January 2001 and January 2018. Eligible registries enrolled pulmonary arterial hypertension patients ≥18 years, N > 30, and reported survival by functional class. Randomized, controlled trial inclusion criteria were pulmonary arterial hypertension patients ≥18 years, ≥6 months of treatment, and morbidity, mortality, or time to worsening as end points reported by functional class. The primary outcomes were survival for registries and clinical event rates for randomized, controlled trials. Separate random effects models were calculated for registries and randomized, controlled trials. Four randomized, controlled trials (n = 2482) and 10 registries (n = 6580) were included. Registries enrolled 9%-47% functional class I/II patients (the vast majority being functional class II) with various pulmonary arterial hypertension etiologies. Survival rates for functional class I/II patients at one, two, and three years were 93% (95% confidence interval (CI): 91%-95%), 86% (95% CI: 82%-89%), and 78% (95% CI: 73%-83%), respectively. The hazard ratio for the treatment effect in randomized, controlled trials overall was 0.61 (95% CI: 0.51-0.74) and 0.60 (95% CI: 0.44-0.82) for functional class I/II patients and 0.62 (95% CI: 0.49-0.78) for functional class III/IV. The calculated risk of death of 22% within three years for functional class I/II patients underlines the need for careful assessment and optimal treatment of patients with functional class I/II disease. The randomized, controlled trial analysis demonstrates that current medical therapies have a beneficial treatment effect in this population.

Dataset Information

Statins Have No Additional Benefit for Pulmonary Hypertension: A Meta-Analysis of Randomized Controlled Trials.

Objectives

Methods

Results

Conclusions

Publications

Statins Have No Additional Benefit for Pulmonary Hypertension: A Meta-Analysis of Randomized Controlled Trials.

Similar Datasets

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